Replies to post #11424 on RespireRx Pharmaceuticals Inc (fka RSPI)

[wahjjhugo]

Why don't I remember any Fragile X trial?

[gfp927z]

One of the problems with being on the outs with Psychiatric, is that applying for future AMPA trials with them could be a problem. As an indication, we know ADHD is out for the forseeable future, regardless of the compound. But Schizo and Depression are also under the purview of Psychiatric (Neuro, please correct me if I'm wrong), so getting new trials approved for these might conceivably be tougher than before, regardless of the particular AMPA compound.

A related concern is the potential for heightened tox requirements for CX-701 and future low impacts prior to allowing trials to proceed. One thing Cortex doesn't need right now is having to do a whole new battery of tox tests for CX-701 prior to the FDA allowing human trials.

[Aiming4]

Dew's post on Ampakine platform from a few days ago... #Msg-23607298

Dew posted this last Thursday after the IND decision, it's another viewpoint and opinion that the Ampakine platform could be in question. I disagree with the conclusion, but Dew has summarized some good points to think about and it makes a companion piece to the Yale Asst. Professor's comments... Aiming4.

COR addendum:

I think it’s reasonable to say that COR’s entire low-impact Ampakine platform is in doubt. Let’s recap:

COR’s first attempt was in mild cognitive impairment (MCI) and that effort failed. The failure was blamed on poor pharmacokinetics of an older drug in the platform, but there was no attempt to resuscitate the MCI program by using a drug with better PK. Instead, the indication was simply dropped.

COR’s next effort was in excessive daytime sleepiness (EDS) and that effort failed. The failure was blamed on poor trial design, but there was no attempt to resuscitate the EDS program by using a better trial design Instead, the indication was simply dropped.

COR’s latest effort was in ADHD and that effort initially appeared to be a modest success. However, the FDA cited safety issues with the drug, and the program’s failure is now being blamed (by posters on the COR iHub board) on… politics! Evidently, there will be no attempt to resuscitate the ADHD program; instead, the indication will simply be dropped.

Now management says the best-suited indication for low-impact Ampakines is respiratory depression (RD), which had never even been mentioned to investors until a few months ago.

In summary, the lead indication has bounced around from MCI to EDS to ADHD to RD and there is yet to be any indication where any COR drug is effective and safe enough to continue testing.

It looks to me as though COR’s low-impact Ampakines are a dubious platform desperately seeking some indication. In other words, Zebra’s Law appears to be in play.

[enemem]

Sanfilippo's thesis hinges on whether or not the FDA's decision was grounded in the science. So far, I've gone along with what COR has claimed, namely that the problems seen in the histological samples harvested from some animals exposed to 70X the clinical dose was due to artifact. If we're being misled on that count we're in a hopeless situation here, because we don't have access to valid information.

I think the FDA could have ruled against CX-717 sight-unseen, because it's an entirely new compound, because the drug would ultimately be taken by kids, and because it's not life-threatening. This is supported by the absurdity of a 70x dosing. Basically, I think that the rejection of cor's proposal says nothing about the compounds, and everything about the regulatory environment.

This article is useful though, because I think it represents the consensus of those who know anything at all about COR. SP is going to stay below a dollar until this consensus is replaced. This will require well-designed trials, and some unambiguous successes.